Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

China Drug Regulator Mulls Tightening Conditional Approvals

Executive Summary

A senior official at China’s National Medical Products Administration recently disclosed that the agency was moving to "rigorously" prevent the accelerated approval pathway from becoming distorted.

You may also be interested in...



Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur

Biotech sponsors understandably discuss accelerated approval as an important consideration in development plans. But the head of the US FDA oncology program has a reminder for them: the pathway is intended to serve patients – not drug companies.

China Biotech Podcast: Shanghai Policy, US Draft Biosecure Bill, MNCs' China Strategy

Brian Yang, Dexter Yan and guest speaker Kevin Grogan from the UK discuss Shanghai's latest policy to spur biopharma investment, the US House's recent draft bill to restrict bio service providers from China, and multinationals' strategies in China and views on Chinese innovation.

China’s Public Payer Proposes Relaxing Novel Chemical Drug Pricing

Only drugs awarded high points under a government-designated scoring method will benefit most from a new pricing scheme in China. The criteria include the products’ innovativeness in terms of pharmaceutical sciences, the clinical value for patients and clinical evidence from clinical studies.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147464

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel